Registration Dossier
Registration Dossier
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EC number: 209-527-2 | CAS number: 584-03-2
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- 1,2-BUTANEDIOL CAS No: 584-03-2
- Author:
- OECD
- Year:
- 2 002
- Bibliographic source:
- SIDS publication - Vol.1 Part 2
- Reference Type:
- review article or handbook
- Title:
- Safety assessment of 1,2-glycols as used in cosmetics
- Author:
- Johnson W Jr et al.
- Year:
- 2 012
- Bibliographic source:
- Int J Toxicol. 2012 Sep-Oct;31(5 Suppl):147S-68S.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Butane-1,2-diol
- EC Number:
- 209-527-2
- EC Name:
- Butane-1,2-diol
- Cas Number:
- 584-03-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,2-diol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Distilled water
Doses / concentrations
- Remarks:
- Doses / Concentrations:
40-1000 mg/kg BW
Basis:
no data
- No. of animals per sex per dose:
- Male 10/Dose (10 controls)
Female 10/Dose (10 controls) - Control animals:
- yes
- Details on study design:
- Daily oral gavage of 0 (negative control), 40, 200, or 1000mg/kg body weight/day for 42 days for males. Females were exposed from day 14 before
mating to day 3 of lactation.
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male
- Remarks on result:
- other: Generation not specified (migrated information)
- Dose descriptor:
- other: EDLC
- Effect level:
- 0.2 other: mg/kg/day
- Sex:
- male
- Remarks on result:
- other: Generation not specified (migrated information)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
NOAEL: 200mg/kg body weight/day was the dose at which no toxic effects were observed.
EDLC: 0.2mg/kg/day was calculated as estimated dose of low concern for repeated dose toxicity.
There were no death throughout the observation period of 42 days. Body weight, food consumption, hematology parameters, clinical chemistry parameters, organ weight, or pathological examination between the treated and control animals did not show any visible differences.
Transient hypolocomotion and hypopnea at the 1000mg/kg in females.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
